SPL v1
SPL
SPL Set ID 9f273f6f-6ea0-7c97-e053-2995a90a4c24
Route
TOPICAL
Published
Effective Date 2020-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.2 g) Pyrithione Zinc (0.6 g) Dexpanthenol (0.5 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-02-22

Description

zinc pyrithione, dexpanthenol, salicylic acid


Medication Information

Warnings and Precautions

1. If skin develops abnormal symptoms or side effects such as red spots, swelling, and itching while or after using the product, or if the application area develops the symptoms above after exposure to direct sunlight, consult your dermatologist. 2. Do not apply on areas with open wounds. 3. Storage & Handling (1). Keep out of reach of children. (2) Keep away from direct sunlight. 4. If the product gets into eyes, rinse immediately with water 5. If you do not rinse thoroughly with water after use, it may cause hair loss or discoloration.

Indications and Usage

Helps alleviate symptoms of hair loss

Description

zinc pyrithione, dexpanthenol, salicylic acid

Section 50565-1

Keep Out of Reach of Children

Section 51945-4

Section 55105-1

Helps alleviate symptoms of hair loss

Directions

Use once a day as follows: 1) Fully wet hair and scalp with lukewarm water. 2) Dispense an appropriate amount in your palm and evenly apply on hair and scalp. 3) After 2-3 minutes, rinse with lukewarm water.

Active Ingredient

zinc pyrithione, dexpanthenol, salicylic acid

Inactive Ingredient

Water, Dipropylene Glycol, Propylene Glycol, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Stearamidopropyl Dimethylamine, Behentrimonium Chloride, CetylEthylhexanoate, PPG-3 Caprylyl Ether, Steartrimonium Chloride, Panthenol, Citrus Limon (Lemon) Peel Oil, AnibaRosodora (Rosewood) Wood Oil, Caprylyl Glycol, Zinc Pyrithione, Salicylic Acid, Hydroxyethylcellulose, Citrus Reticulata (Tangerine) Peel Oil, Niacinamide, Butylene Glycol, Sodium Polynaphthalenesulfonate, 1,2-Hexanediol, Glycine, Glycine Max (Soybean) Seed Extract, VignaRadiata Seed Extract, ArchisHypogaea (Peanut) Fruit Extract, PisumSativum (Pea) Seed Extract, CanavaliaGladiata Extract, PhaseolusAngularis Seed Extract, SesamumIndicum (Sesame) Seed Extract, VacciniumAngustifolium (Blueberry) Fruit Extract, Salvia Hispanica Seed Extract, Nigella Sativa Seed Extract, RubusFruticosus (Blackberry) Fruit Extract, RibesNigrum (Black Currant) Fruit Extract, Oryza Sativa (Rice) Extract, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, OenotheraBiennis (Evening Primrose) Flower Extract, UlmusDavidiana Root Extract, PinusPalustris Leaf Extract, PuerariaLobata Root Extract, Histidine, Methionine, Cysteine, Ethylhexylglycerin, Hydrolyzed Corn Protein, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Acacia Senegal Gum, Sodium Polynaphthalenesulfonate, Peat water, Citric Acid, Hydroxypropyl Methylcellulose, Potassium Sorbate


Structured Label Content

Indications and Usage (34067-9)

Helps alleviate symptoms of hair loss

Warnings and Precautions (34071-1)

1. If skin develops abnormal symptoms or side effects such as red spots, swelling, and itching while or after using the product, or if the application area develops the symptoms above after exposure to direct sunlight, consult your dermatologist. 2. Do not apply on areas with open wounds. 3. Storage & Handling (1). Keep out of reach of children. (2) Keep away from direct sunlight. 4. If the product gets into eyes, rinse immediately with water 5. If you do not rinse thoroughly with water after use, it may cause hair loss or discoloration.

Section 50565-1 (50565-1)

Keep Out of Reach of Children

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps alleviate symptoms of hair loss

Directions

Use once a day as follows: 1) Fully wet hair and scalp with lukewarm water. 2) Dispense an appropriate amount in your palm and evenly apply on hair and scalp. 3) After 2-3 minutes, rinse with lukewarm water.

Active Ingredient (ACTIVE INGREDIENT)

zinc pyrithione, dexpanthenol, salicylic acid

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Dipropylene Glycol, Propylene Glycol, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Stearamidopropyl Dimethylamine, Behentrimonium Chloride, CetylEthylhexanoate, PPG-3 Caprylyl Ether, Steartrimonium Chloride, Panthenol, Citrus Limon (Lemon) Peel Oil, AnibaRosodora (Rosewood) Wood Oil, Caprylyl Glycol, Zinc Pyrithione, Salicylic Acid, Hydroxyethylcellulose, Citrus Reticulata (Tangerine) Peel Oil, Niacinamide, Butylene Glycol, Sodium Polynaphthalenesulfonate, 1,2-Hexanediol, Glycine, Glycine Max (Soybean) Seed Extract, VignaRadiata Seed Extract, ArchisHypogaea (Peanut) Fruit Extract, PisumSativum (Pea) Seed Extract, CanavaliaGladiata Extract, PhaseolusAngularis Seed Extract, SesamumIndicum (Sesame) Seed Extract, VacciniumAngustifolium (Blueberry) Fruit Extract, Salvia Hispanica Seed Extract, Nigella Sativa Seed Extract, RubusFruticosus (Blackberry) Fruit Extract, RibesNigrum (Black Currant) Fruit Extract, Oryza Sativa (Rice) Extract, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, OenotheraBiennis (Evening Primrose) Flower Extract, UlmusDavidiana Root Extract, PinusPalustris Leaf Extract, PuerariaLobata Root Extract, Histidine, Methionine, Cysteine, Ethylhexylglycerin, Hydrolyzed Corn Protein, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Acacia Senegal Gum, Sodium Polynaphthalenesulfonate, Peat water, Citric Acid, Hydroxypropyl Methylcellulose, Potassium Sorbate


Advanced Ingredient Data


Raw Label Data

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